On Thursday, H.C. Wainwright adjusted its price target for HOOKIPA Pharma Inc. (NASDAQ:HOOK) shares, reducing it to $5.00 from the previous $6.50. The firm maintained a Buy rating despite the target change. The adjustment followed HOOKIPA Pharma's announcement regarding the trial design of a Phase 2/3 pivotal study for its HB-200 program on Wednesday.
The HB-200 treatment, consisting of HB-201/HB-202, is currently under investigation in combination with pembrolizumab for first-line treatment of recurrent/metastatic Human Papillomavirus 16 positive (HPV16+) head and neck squamous cell carcinoma (HNSCC).
The study is expected to concentrate on a subset of HNSCC patients, specifically those with oropharyngeal squamous cell carcinoma (OPSCC) and a PD-L1 CPS of 20 or greater.
The trial is designed in alignment with the FDA's feedback from a Type C meeting, aiming to enroll approximately 250 OPSCC patients. These patients will be randomized in a 1:1 ratio to receive either HB-200 plus pembrolizumab or a placebo in combination with pembrolizumab. The primary endpoints set for the Phase 2 and Phase 3 parts of the study are overall response rate (ORR) and overall survival (OS), respectively.
Secondary endpoints of the study include duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), as well as safety and tolerability assessments.
HOOKIPA Pharma anticipates initiating patient dosing in the fourth quarter of 2024 and plans to release Phase 2 topline data in 2026 once 125 patients are evaluable for ORR. Positive ORR results could lead to an application for accelerated approval of HB-200.
The outcome for overall survival from the Phase 3 portion of the study is expected to be available in 2028. H.C. Wainwright's commentary reflects optimism about the potential of HB-200 in combination with pembrolizumab to offer a more effective, chemotherapy-free treatment option compared to the current standard of care for this patient population. The firm reiterated its Buy rating while adjusting the price target to reflect the narrower initial target patient population than anticipated.
InvestingPro Insights
As HOOKIPA Pharma Inc. (NASDAQ:HOOK) focuses on the pivotal trial for its HB-200 program, real-time data and insights from InvestingPro could shed light on the company's financial health and market performance. The company's market cap stands at a modest $79.76M, and it has experienced a significant 41.27% revenue growth over the last twelve months as of Q4 2023. This growth, however, is contrasted by a quarterly revenue decline of -5.38% in Q4 2023. Notably, HOOKIPA Pharma has been grappling with negative gross profit margins, with gross profit at -$64.95M and a staggering operating income margin of -421.92% for the same period.
On the brighter side, HOOKIPA’s stock has shown resilience in the market with a strong 83.62% price total return over the last six months, and analysts have revised their earnings upwards for the upcoming period, signaling potential optimism in the company’s future performance. Nevertheless, with a negative P/E ratio and analysts not anticipating profitability this year, investors should approach with caution. For those seeking further analysis, InvestingPro offers additional insights and metrics; there are 11 more InvestingPro Tips available for HOOKIPA Pharma, which can be accessed through the dedicated page at https://www.investing.com/pro/HOOK. To enhance your investing strategy, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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